The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Ca-1000/sysmex Ca-5000.
Device ID | K964946 |
510k Number | K964946 |
Device Name: | SYSMEX CA-1000/SYSMEX CA-5000 |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
Contact | Margaret Barranco, Ma, Mt (ascp) |
Correspondent | Margaret Barranco, Ma, Mt (ascp) SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
Product Code | JPA |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-10 |
Decision Date | 1997-03-18 |
Summary: | summary |